First and only FDA-approved medication that may help you stay pregnant longer1
Every week counts when you’re pregnant
Makena® (hydroxyprogesterone caproate injection), pronounced Ma-keen-a, is an FDA-approved hormone medicine (progestin) prescribed to lower the risk of having a preterm baby in women1:
- Who are pregnant with one baby, and
- Who’ve unexpectedly delivered one baby too early (before 37 weeks) in the past
Makena is a weekly injection given (every 7 days) by your healthcare provider either at their office or in your home.1
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Why choose FDA approved?
FDA-approved products, like Makena, provide greater assurance of quality and are held to high quality standards compared to products that are not approved by the FDA.
FDA: Food and Drug Administration.
Your baby needs every week of pregnancy to develop.2-4 For example, your baby's brain and lungs are still developing in the last few weeks of pregnancy.4
In clinical studies, taking Makena significantly lowered the rate of preterm birth compared to moms who did not take Makena.1
- Makena was studied in women who were at risk for having a preterm baby because they had given birth to a preterm baby before1
- It’s not known whether Makena is safe and effective in women who have other risk factors for preterm birth1
- Makena is not intended for use to stop active preterm labor1
Only your healthcare provider can prescribe FDA-approved Makena. Ask today if it’s right for you.
See if you are at risk for a preterm birth and if Makena is right for youSee more videos
Makena is the first and only FDA-approved medicine to reduce the risk of preterm birth in women who are currently pregnant with one baby and who have unexpectedly delivered a baby preterm (before 37 weeks) in the past.1
Makena is made in a facility that follows FDA’s Good Manufacturing Practices (GMPs).5,6 Before it was approved, the FDA thoroughly reviewed the safety, efficacy, and manufacturing quality. This ensures quality of the product including5-7:
- The right drug
- The right amount of drug
- Free of contamination
- Sterile
The majority of drugs used in the United States are FDA approved and made under GMPs. Occasionally, due to a patient’s unique medical need, a pharmacist may need to compound an alternative formulation. Compounded drugs are not FDA approved and should only be prescribed when a patient has a medical need that can’t be met with the approved drug.8
Learn why FDA approval is importantSee more videos
Understand the benefits of taking an FDA-approved medication
Jennifer Gudeman, PharmD, Vice President, Medical Affairs, Maternal Health, describes the FDA’s statement that FDA-approved medications should be used when medically appropriate rather than compounded formulations, unless there is a specific medical need for the patient.
Using Makena
-
Makena is an injection given by a healthcare provider1:
- In the healthcare provider’s office or
- At home during a home healthcare visit (if covered by your insurance)
-
You will get one injection into your hip (upper outer area of your buttocks) each week until week 37 or until you deliver your baby—whichever happens first1
- Injections start between week 16 and week 20, 6 days of your pregnancy, depending on your healthcare provider’s direction1
What to expect with your injections of Makena
View a video
Home injections by healthcare professionals
Weekly injections of Makena may be administered in your home by a trained healthcare professional, if approved by your insurance plan.
Makena may help you stay pregnant longer. See how
You and your healthcare provider should consider the benefits and risks of treatment with Makena prior to deciding if Makena is right for you.
Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.
What are the potential side effects?
For moms:
Makena may cause serious side effects including1:
- Blood clots—Symptoms of a blood clot may include leg swelling, redness in your leg, a spot on your leg that is warm to touch, or leg pain that worsens when you bend your foot
- Allergic reactions—Symptoms of an allergic reaction may include hives, itching, or swelling of the face
- Depression
- Yellowing of your skin and the whites of your eyes
The most common adverse reactions observed with Makena were injection site reactions (pain, swelling, itching, bruising, or a hard bump), hives, itching, nausea, and diarrhea.1
In a clinical study, certain complications or events associated with pregnancy occurred more often in women who received Makena. These included miscarriage (pregnancy loss before 20 weeks of pregnancy), stillbirth (fetal death occurring during or after the 20th week of pregnancy), hospital admission for preterm labor, preeclampsia (high blood pressure and too much protein in your urine), gestational hypertension (high blood pressure caused by pregnancy), gestational diabetes, and oligohydramnios (low amniotic fluid levels).1
For babies:
In a follow-up study, children between the ages of 2 and 5 years old were evaluated for development in various physical, mental, and social measures. The results were similar to children born to non–Makena-treated moms.9
Consider the potential side effects of MakenaSee more videos
Get help paying for Makena. Find out how
Indication
Makena (hydroxyprogesterone caproate injection) is a prescription hormone medicine (progestin) used to lower the risk of preterm birth in women who are pregnant with one baby and who have delivered one baby too early (preterm) in the past. Makena was shown to work based on a lower number of women who delivered babies at less than 37 weeks of pregnancy. There are no studies showing Makena reduces the number of babies who have serious problems shortly after birth or who die. It is not known whether Makena is safe and effective in women who have other risk factors for preterm birth.
Important Safety Information for Makena (hydroxyprogesterone caproate injection)
Makena should not be used in women with any of the following conditions: blood clots or other blood clotting problems, breast cancer or other hormone-sensitive cancers, or history of these conditions; unusual vaginal bleeding not related to your current pregnancy, yellowing of the skin due to liver problems during pregnancy, liver problems, including liver tumors, or uncontrolled high blood pressure.
Before you receive Makena, tell your healthcare provider if you have an allergy to hydroxyprogesterone caproate, castor oil, or any of the other ingredients in Makena; diabetes or prediabetes, epilepsy, migraine headaches, asthma, heart problems, kidney problems, depression, or high blood pressure.
In a clinical study, certain complications or events associated with pregnancy occurred more often in women who received Makena. These included miscarriage (pregnancy loss before 20 weeks of pregnancy), stillbirth (fetal death occurring during or after the 20th week of pregnancy), hospital admission for preterm labor, preeclampsia (high blood pressure and too much protein in your urine), gestational hypertension (high blood pressure caused by pregnancy), gestational diabetes, and oligohydramnios (low amniotic fluid levels).
Makena may cause serious side effects including blood clots, allergic reactions, depression, and yellowing of your skin and the whites of your eyes. Call your healthcare provider right away if you think you have symptoms of a blood clot (leg swelling, redness in your leg, a spot on your leg that is warm to touch, or leg pain that worsens when you bend your foot) or symptoms of an allergic reaction (hives, itching, or swelling of the face). The most common side effects of Makena include injection site reactions (pain, swelling, itching, bruising, or a hard bump), hives, itching, nausea, and diarrhea.
You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Please see full Prescribing Information for Makena.
References: 1. Makena® (hydroxyprogesterone caproate injection) prescribing information, AMAG Pharmaceuticals, 2016. 2. American College of Obstetrics and Gynecology. Preterm (premature) labor and birth. http://www.acog.org/~/media/For%20Patients/faq087.pdf?dmc=1&ts=20130207T1252359850. May 2013. Accessed January 5, 2017. 3. March of Dimes. Long-term health effects of premature birth. http://www.marchofdimes.org/baby/long-term-health-effects-of-premature-birth.aspx. October 2013. Accessed January 5, 2017. 4. Engle WA, Tomashek KM, Wallman C. Late-preterm infants: a population at risk. Pediatrics. 2007;120:1390-1401. 5. US Food and Drug Administration. FDA’s drug review process. http://www.fda.gov/Drugs/ResourcesForYou/Consumers/ucm289601.htm. August 24, 2015. Accessed January 5, 2017. 6. Sellers S, Utian WH. Pharmacy compounding primer for physicians. Drugs. 2012;72:2043-2050. 7. US Food and Drug Administration. Updated FDA statement on compounded versions of hydroxyprogesterone caproate (the active ingredient in Makena). https://wayback.archive-it.org/7993/20170112232040/http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm308546.htm. June 15, 2012. Accessed March 29, 2017. 8. US Food and Drug Administration. Questions and answers on updated FDA statement on compounded versions of hydroxyprogesterone caproate (the active ingredient in Makena). http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm310215.htm. June 29, 2012. Accessed January 5, 2017. 9. Northen AT, Norman GS, Anderson K. Follow-up of children exposed in utero to 17 α-hydroxyprogesterone caproate compared with placebo. Obstet Gynecol. 2007;110:865-872.
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